# FDA recall Z-1052-2019

> **Philips North  America, LLC** · Class II · device recall initiated 2019-02-28.

## Product

MultiDiagnost-Eleva, Product codes 708032, 708036    Product Usage:  As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas:   Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS)   Skeletal system: Bone studies.   Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement   Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography   Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies   Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement.   Various: Arthrograms, Myelograms, Facet joint injections, Disc

## Reason for recall

The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.

## Distribution

US Nationwide domestic distribution, and worldwide international distribution.

## Key facts

- **Recall number:** Z-1052-2019
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-28
- **Report date:** 2019-04-03
- **Termination date:** 2020-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1052-2019

## Citation

> AI Analytics. FDA recall Z-1052-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1052-2019. Source: US FDA. Licensed CC0.

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